Omron HEM Solar (HEM-4500-Sole)

Description:

The Omron HEM Solar (HEM-4500-Sole) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The technology used in the Omron HEM Solar (HEM-4500-Sole), to measure blood pressure, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Previous recommendation, now archived	Manufacturer declaration of equivalence
BP	ESH (Europe)	Self-measurement	Published evidence
BP	Japanese Society of Hypertension	Self-measurement (2016-2021)	Implied equivalence to the Omron M1 Plus (HEM-4011C-E), M6 Comfort (HEM-7321-E), Spengler KP7500 D, Microlife BP A100 Plus

Device Family:

Omron HEM Solar (HEM-4500-Sole)B,D,J, Omron M1 (HEM-4030-E)B,D, Omron M1 Classic (HEM-442C-E)D, Omron M1 Compact (HEM-4022-E)B,D, Omron M1 Plus (HEM-4011C-E)B,D,J
Legend: B BIHS Derivative, D DET Equivalence, J JHS Implied Equivalence

Validation Publications:

Parati G, Kilama MO, Faini A, Facelli E, Ochen K, Opira C, Mendis S, Wang J, Atkins N, O'Brien E. A new solar-powered blood pressure measuring device for low-resource settings. Hypertension. 2010 Dec;56(6):1047-53. Epub: 2010 Nov 8. doi: 10.1161/HYPERTENSIONAHA.110.160408. PMID: 21059998. Available from: hyper.ahajournals.org.

ESH-IP:2002 - Fail General population (Note: Passed SBP)

Study includes field test in LR settings

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Omron M1 Plus (HEM-4011C-E)

Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2007;3(4):389-400. PMID: 17969368. Available from: PMC2291343.

ESH-IP:2002 - Pass General population